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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03242564
Other study ID # Vev-2017-1
Secondary ID
Status Completed
Phase N/A
First received July 26, 2017
Last updated August 3, 2017
Start date July 10, 2017
Est. completion date July 21, 2017

Study information

Verified date August 2017
Source Vevazz, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether red light therapy using LED 650nm red light for body contouring of the waist, hips and thighs is as effective as red light therapy using Laser 635nm red light.


Description:

Red light laser therapy using 635nm red light laser technology has previously been shown to cause lipolysis in subcutaneous fat as a non-surgical method to promote weight loss and body contouring. This study hypothesizes that red LED light therapy using 650nm red light LED (light emitting diode) technology produces similar results to the laser device (red LASER 635nm) when preformed using a specified treatment protocol.

Furthermore, it is hypothesized that the Vevazz therapy program achieves the results after a single 28 minute treatment. The predicate 635nm LED device (Photonica Professional by Ward Photonics) achieves its results after one 32 minute therapy program.

The Vevazz therapy program uses the Vevazz LED device for fat removal using LED red light therapy. This multi-site study reviews results from 66 randomly selected patients after a single treatment using the Vevazz LED device.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date July 21, 2017
Est. primary completion date July 21, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 77 Years
Eligibility Inclusion Criteria:

- At least 18 years or older.

- May be male or female.

- Generally good health.

Exclusion Criteria:

- Minors.

- Open wounds or sores.

- Pacemaker.

- Photosensitivity.

- Epilepsy.

- Any form of cancer.

- Severe kidney or liver problems.

- Thyroid problems.

- Pregnant or nursing.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Vevazz LED
Vevazz LED red light therapy is a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist and thighs.

Locations

Country Name City State
United States Vevazz, LLC Dallas Texas

Sponsors (1)

Lead Sponsor Collaborator
Vevazz, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Fat Amount (Reduction) in Treatment Area as Measured in Inches Lost Circumferential measurement of thighs, hips and waist before and after treatment. One 28 minute treatment session.
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